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Biologic drugs play a key role in the US healthcare market, as they are often the standard of care for treating complex diseases, many of which require long-term treatment. With the FDA’s approval of biosimilars of several important biologic treatments, and with a significant pipeline of biosimilars still in development, it is expected that many biosimilars will be introduced to the US market in the next several years.

JHL Biotech, a biopharmaceutical startup based in Taiwan, announced yesterday that it has submitted a phase 1 clinical trial application to the Dutch Healthcare Authority for its proposed dornase alfa biosimilar, JHL1922, to improve pulmonary function in patients with cystic fibrosis.

Tax disclosure forms for 2016 show that the pharmaceutical industry’s biggest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), raised revenue by almost one-fourth and spent the millions collected among hundreds of lobbyists, politicians, and patient groups—the largest income surge reported by the group since 2009, when it was mobilizing forces to advance the industry’s interests prior to the passage of the Affordable Care Act.

Hikma Pharmaceuticals Plc. announced yesterday that it has reached a licensing agreement with Republic of Korea-based Celltrion for its rituximab biosimilar, Truxima, referenced on MabThera.

Last week’s ruling in the federal circuit, which held that state law cannot compel biosimilar applicants to participate in the Biologics Price Competition and Innovation Act (BPCIA) “patent dance,” has raised questions about how the case will impact the BPCIA in the days ahead. Yet Kevin M. Nelson, JD, partner at Schiff Hardin’s Hatch-Waxman and biosimilars practice, told The Center for Biosimilars® in an interview, that, “For the BPCIA, I don’t think it means much.” In Nelson’s view, the most significant impact that the ruling will have is on the early case assessments that biosimilar applicants undertake when determining whether they will take part in the information exchange process.

Republic of Korea-based Samsung Bioepis announced on Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB3, a proposed trastuzumab biosimilar, referenced on Herceptin. If the FDA approves SB3, the drug will be commercialized in the US by Merck.

Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why REMS programs give biosimilar and generic drug developers cause for concern.

Republic of Korea-based biosimilar developer Celltrion announced on December 16 that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar, referenced on Roche’s blockbuster anticancer therapy, Herceptin. The positive opinion will now be referred to the European Commission for final review.

How much do analysts believe the top 10 biggest-selling drugs will earn in 2018? Our latest infographic breaks down the projections.

Teva Pharmaceutical Industries, the world’s largest generic drug maker, based in Israel, unveiled its restructuring plan yesterday, which comes with big cuts to its research and development (R&D) department and staff.

Improvements in the efficiency of certain research and development (R&D) processes and the wider adoption of new technologies are cause for optimisim.

Recently, the Prescription Medicines Code of Practice Authority announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s Code of Practice.

The Center for Biosimilars® recaps the top 5 articles for the week of December 11.

Hospitals classified as 340B institutions are playing an increasingly large role in oncology care, and the rapid growth in the federal 340B program has resulted in big changes in the oncology drug marketplace, according to a recent white paper released by the Community Oncology Alliance.

The federal circuit ruled today in Amgen v Sandoz that state law cannot compel drug makers to participate in the so-called “patent dance” provided for in the Biologics Price Competition and Innovation Act because state law cannot preempt federal law.

Pfizer announced on December 13 that the FDA has approved Ixifi, PF-06438179, infliximab-qbtx, the company’s second biosimilar to the reference infliximab, Remicade.

On December 13, the House of Representatives Committee on Energy and Commerce’s Subcommittee on Health heard testimony from a variety of healthcare stakeholders in a hearing titled “Examining the Drug Supply Chain.” During the proceeding, a follow-up to a hearing on implementation of the 21st Century Cures Act, several witnesses focused their attention on the promise of—and challenges specific to—biosimilars in the US marketplace.

A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed.

Palivizumab (Synagis) is a monoclonal antibody that is used to help prevent respiratory syncytial virus (RSV). RSV is a common virus that can cause serious lung infections in infants who are at high risk, including premature infants or those who have certain heart and lung diseases.

Roche has announced positive data on 2 of its innovator oncology biologics in combination with other therapies. The combinations using rituximab (MabThera, Rituxan) and bevacizumab (Avastin) could help the Swiss drug maker to protect sales of these monoclonal antibodies in the face of oncoming biosimilar competition.

The pharmaceutical industry trade and lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) sued California state officials in federal court on December 8, 2017, over California’s new drug pricing law, which the group states is “unprecedented and unconstitutional.”

The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.

Evaluate Group’s EP Vantage pharma and biotech preview of 2018 predicts that the uptick in the pharmaceutical and biotech sectors that occurred in 2017 is likely to continue into 2018.

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

Results from a phase 1 clinical trial show that Sandoz’s proposed pegfilgrastim biosimilar (LA-EP2006) matched the reference biologic, Amgen’s Neulasta, in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects.

The Center for Biosimilars recaps the top 5 articles for the week of December 4.

USV has announced that the European Medicines Agency (EMA) has accepted for review its application for a proposed pegfilgrastim biosimilar.

A new report from calls for big changes in how US pharmaceuticals are priced, promoted, and sold so that treatments are more affordable and equally available to all Americans, as market mechanisms that would usually moderate prices have been blunted or eliminated.

Novo Nordisk has announced new data on its development of a next-generation insulin that could help the company stave off biosimilar and follow-on insulin competition. Meanwhile, Sanofi announced that its own insulin met its main objective in a head-to-head study versus Novo Nordisk’s product.